Periodic Reporting for period 1 - CareInTrials (Care in Clinical Trials involving Youth. Exploring Vulnerability through Empirical Philosophy in a Clinical Trials Unit.)
Reporting period: 2021-04-01 to 2023-03-31
CareInTrials is an empirical philosophy study, which makes use of qualitative methods to provide a philosophical reading of the experiences of youth participating in clinical trials. It pursues three main objectives: 1) it analyzes how international ethical guidelines and regulations have problematized the ethical issues at stake with minors’ participation in research over the years; 2) it observes the daily interactions and communications related to adolescents’ (aged 12-17 y.o.) participation in clinical trials, 3) it explores the meaning making of adolescents (12-17 y.o.) participating in clinical trials, their parents and healthcare professionals.
To meet these objectives, three main methods were used: 1) a document analysis of research ethics guidelines and regulations involving human subjects from 1947 until today; 2) a 9 months ethnographic observation study at La Paz University Hospital; 3) 23 semi-structured interviews with different actors involved in clinical trials (namely, adolescents aged 12-17 years old currently enrolled in clinical trials, their accompanying adults and healthcare workers).
The material thus collected was analyzed through a philosophical analysis that engages with critical understandings of childhood in human and social sciences, the lived experience, and the existential dimension in medicine. A secondment at the “Science, Philosophy and History” (SPHERE) Research Unit (CNRS - University of Paris) was part of the action.
CareInTrials provided insights to current ethical debates and recommendations on pediatric clinical trials and more broadly for pediatric health research and innovation. The philosophical analysis of the experiences and narratives of different actors involved allowed to: 1) highlight the changing perspectives on childhood in biomedical research, 2) provide in-depth accounts of real life situations that show the complexity and nuances that theoretical changes bring to practice, 3) highlight some ethical aspects that could be improved.
The largest part of CareInTrials, however, consisted in conducting fieldwork at the units of Hospital La Paz conducting clinical trials with adolescentes. Before starting this part of the project, we received approval from the Research Ethics Committee of La Paz University Hospital (CEIm, with approval number: PI-4809). Dr Murano then conducted 9 months of ethnographic observations and 23 interviews (of which 9 with minors aged from 12 to 16 years old, 6 accompanying adults and 8 healthcare professionals) in four different trial settings and disciplines: 1) the development of an anti-COVID-19 vaccine, 2) studies on two dermatological diseases, e.g. atopic dermatitis and psoriasis, 2) studies on hemophilia and 3) on the PIK3CA-related overgrowth spectrum. The fieldwork ended in July 2022 and now we are working on the analysis. Some preliminary results highlight the differences of understanding of childhood by different stakeholders (youth, parents, professionals), the focus on trust in others and in science as primary reasons to participate in clinical trials, the absence of reflections on emotions in these settings and the constraints related to current organization of clinical trials practices.
These results might be of interest for all minors volunteering in clinical trials and their families, as well as healthcare professionals in charge of the care of these people. It has also broader relevance for advancing current regulations and ethical guidelines on pediatric health research and could help pharmaceutical companies in setting priorities in the design and development of research projects.